Comprehensive Compliance Plan

Document Sample
Comprehensive Compliance Plan Powered By Docstoc
					Comprehensive
Compliance Plan




Date: February 8, 2006
     Version: 1.0
                   COMPREHENSIVE COMPLIANCE PROGRAM
       Organogenesis is committed to implementing and maintaining an effective Comprehensive
Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical
Manufacturers published by the Office of Inspector General (“OIG”), U.S. Department of Health and
Human Services, as well as the code of Ethics adopted by the Advanced Medical Technology
Association (AdvaMed). The purpose of our Comprehensive Compliance Program (“Compliance
Program”) is to prevent and detect violations of law or company policy. Our Compliance Program
was established by senior management and is a key component of our commitment to the highest
standards of corporate ethics and conduct.

        An effective Comprehensive Compliance Program must be dynamic and responsive to new
developments. We expect to review our Compliance Program regularly and to enhance it over time
to meet our evolving compliance needs. Effective programs also require the commitment and support
of senior management, employees, and the contractors that work with a company. Each employee
and affiliate of Organogenesis must recognize that he or she has assumed a number of ethical and
professional responsibilities by affiliating with Organogenesis, including complying with the
following two fundamental tenets of Organogenesis’ Compliance Program: (a) adherence to our
Standards of Conduct and (b) reporting violations of our Standards of Conduct.

                Complying with Organogenesis’s Standards of Conduct

       As an Organogenesis employee, you are responsible for ensuring that your conduct conforms
to Organogenesis’ Standards of Conduct and all applicable Federal and State laws and regulations. If
at any time you have a question as to whether a procedure or action is inappropriate under the
Standards of Conduct, then you should ask your immediate supervisor. If you do not feel comfortable
discussing the situation with your supervisor, or if you have discussed the matter and remain unclear
as to what is appropriate conduct, then you should speak with the Regulatory Compliance Officer
(“RCO”).

    Any employee who has a question about what constitutes proper conduct is able to consult the
RCO for guidance. This contact may be made confidentially. Our RCO will take the appropriate
steps to investigate a complaint and may institute corrective action if required. The RCO also is
responsible for answering questions about the Standards of Conduct and any Policies and Procedures
that expand upon the Standards and for resolving disputed interpretations. You should have no
hesitation whatsoever in consulting the RCO if you believe it is necessary to do so.

                      Reporting Violations of Standards of Conduct
        All Organogenesis employees must follow the Standards of Conduct detailed herein. This
obligation applies to every employee of Organogenesis, regardless of position. A violation of a
Standard of Conduct is a serious matter. Under appropriate circumstances, and after proper
procedures have been followed, employees may be subject to discipline, up to and including
termination, for violations of the Standards of Conduct.
                                                 1
         It is the responsibility of each employee to report any known or suspected violation of the
Standards of Conduct, any other company policy, or any Federal or State law or regulation. You can
satisfy this reporting obligation either through an oral or a written report. You may send a letter to
the RCO or your supervisor discussing your concerns. Written reports will be treated with the same
degree of confidentiality as oral reports, and they may be anonymous if you prefer. Your report will
be evaluated by the RCO to determine whether an investigation is warranted. Employees should be
assured that retaliation for filing a report of a suspected violation in good faith is absolutely
prohibited, even if the report is not found to be accurate or it is determined that no violation of the
Standards of Conduct or applicable laws occurred.

     Certification of Understanding of Organogenesis’s Standards of Conduct

        As a condition of employment, every Organogenesis director, officer, or employer will be
asked to certify that they (a) have received a copy of the company’s Compliance Program, (b) have
read the Program and the Policies and Procedures amplifying on the Standards of Conduct in the
Program, and (c) will comply with the company’s Standards of Conduct. These certifications will be
retained in each individual’s personnel file. Provisions requiring review of and adherence to the
Compliance Plan will be included in contracts that Organogenesis executes with vendors.

                                The Regulatory Compliance Officer

        Our RCO is responsible for the implementation, operation, and monitoring of the
Organogenesis Comprehensive Compliance Program. The RCO is the Vice President, Regulatory
Affairs. Many of the principal elements of the Compliance Program are under the direction and
supervision of the RCO. The RCO reports to the Chief Executive Officer.

      Our RCO is key to the effective implementation of our Comprehensive Compliance Program.
The RCO’s duties include:

       A.      Development and Implementation of an Investigative Protocol

        The RCO is responsible for reviewing, assessing and, as appropriate, investigating reports of
possible healthcare regulatory misconduct from Company employees, independent contractors or any
one else who contacts the Organogenesis compliance hotline. A report log will be kept in which the
RCO records pertinent data. All reports will be retained in a secure location and may be subject to the
Company’s record retention policy. If the RCO concludes, based upon the initial review of a report,
that the report contains allegations that should be investigated further, the RCO will initiate an
investigation. The RCO is responsible for developing a protocol for the expeditious investigation of
any credible report that alleges a violation of the Company’s Standards of Conduct or applicable law.
If necessary, the RCO may request assistance from Legal Counsel in completing any of these
responsibilities.

      Promptly at the conclusion of any investigation, the RCO will draft a report of findings and
recommendations. The report will contain a summary of the initial report, the steps taken to
                                                  2
investigate the report, the investigative findings, and the recommendations, if any, for corrective
action. This report will be forwarded for review by the Company’s senior management or, if senior
management is implicated in any wrongdoing, or, if applicable, the Board of Directors.

       B.      Development of Audit Protocols

        The RCO will institute a plan for periodic audits and reviews of certain facets of the
Company’s operations, including its sales and marketing practices. The nature of these reviews as
well as the extent and frequency of our monitoring and auditing activities will vary depending upon
perceived regulatory risk, new regulatory requirements, changes in business practices, and other
considerations. Some audits and reviews will be conducted using internal resources. Other may
involve the retention of outside consultants or attorneys. We expect our routine evaluation of
enforcement developments coupled with our periodic assessments of our operations to result in the
identification of new and emerging risk areas that will be addressed through enhancements to our
Compliance Program.

       C.      Design and Coordination of Compliance Training

        The RCO is responsible for the development and coordination of new hire compliance training,
annual sales force training and periodic refresher training for Organogenesis managers, employees and
independent contractors that are involved in regulatory matters. Participation in annual compliance
training will be mandatory. The RCO will create or identify appropriate programs for new and
existing personnel. The focus of the initial compliance training will be the Compliance Program in
general as well as the applicable Federal and State healthcare laws and regulations that apply to
Organogenesis’s operations. When an area of perceived compliance risk involves specialized issues
not of general concern to the entire employee population, the RCO may direct certain employees or
contractors to attend appropriate continuing education courses offered by commercial conference
organizers or government agencies. All participants will be required to sign an attendance sheet at
each internal training session that is conducted or certify attendance at external training sessions.

        Training may be presented in a variety of ways. In-person meetings, video presentations, web-
based training programs, and outside seminars are all acceptable training approaches. For certain
situations, the RCO may also elect to require self-training through the review of documents and the
completion of a certification that the materials have been read. Regardless of the medium used for
training, the RCO maintains an open-door policy and routinely will be available to answer questions
and clarify instructions.

        Organogenesis will regularly review and update its training programs and materials to ensure
that they reflect changes to Organogenesis operations, its Compliance Program, the OIG Compliance
Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code, and applicable law.
Organogenesis may also identify additional areas of training on an as-needed basis.




                                                 3
       D.      Establishment of Internal Lines of Communication

        It is the responsibility of the RCO to maintain contact with Legal Counsel and other sources in
order to keep the Company aware of new regulatory and legal developments affecting its operations,
particularly those relating to sales and marketing. It is also the duty of the RCO to disseminate to the
appropriate Company personnel information concerning regulatory and legal developments. Normally
this will be accomplished through memoranda or circulated copies of the pertinent regulations, laws,
or other documents. The RCO, however, should be prepared to conduct or arrange for compliance
workshops if extensive and complicated changes must be implemented and new procedures developed
as a consequence of any statutory or regulatory development.

       Just as importantly, the RCO also must foster dialogue between management and employees.
The RCO must ensure that all employees and contractors know who to turn to for a meaningful
response to a compliance question and how to report suspected violations of the company’s Standards
of Conduct. The RCO also must ensure that our employees and our contractors feel free to ask
questions or report concerns, knowing that they may do so without fear of retribution. Organogenesis
operates under an open-door policy and follows confidentiality and non-retaliation policies as well.
We also have set up a toll-free telephone system to handle questions or complaints that individuals
want to raise anonymously.

       E.      Due Diligence Oversight of Employee and Contractor Selection

        Organogenesis will not employ or contract with any individual or entity that (a) has been
convicted of a criminal offense related to health care, or (b) is debarred, excluded, or otherwise
ineligible for participation in federal health care programs. Every new director, officer, manager,
employee and contractor is screened through the OIG and GSA listings of excluded individuals and
that no one appearing on the list is hired. Organogenesis also will conduct appropriate additional
background checks on all such individuals.

        Periodically and as necessary, Organogenesis will rerun the names of managers and current
staff involved in sales and marketing through the OIG and General Services Administration (“GSA”)
exclusion listings. Furthermore, all individuals or entities employed by, under contract with or
otherwise affiliated with Organogenesis must notify Human Resources or the RCO immediately if
they are charged with a criminal offense related to health care or become subject to a debarment or
exclusion proceeding. Failure to provide such notice could result in termination.

       F.      Oversight of Disciplinary Actions

       The RCO will be responsible for ensuring that any officer, employee, or contractor of
Organogenesis who is found to have violated the Standards of Conduct is disciplined in an
appropriate, measured, and consistent fashion. Senior management shall review all significant
decisions on an annual basis to ensure that this standard has been met.

      All managers and supervisors should take appropriate action to identify any misconduct
committed by employees or others whom they supervise. Managers may be subject to discipline for

                                                  4
failure to detect compliance violations that occur to the extent that the manager is negligent in this
duty. If a manager or supervisor, through negligence, carelessness, or inattention, facilitates or
prolongs misconduct, then an appropriate penalty based on the seriousness of the offense will be
imposed.

       Organogenesis acknowledges that different categories of conduct may exist (i.e., simple
negligence, gross negligence, or willful misconduct) and this will be taken into consideration when
determining the appropriate discipline. Certain offenses may justify immediate termination of
employment:

               (1)     Violation of any Federal or State criminal statute;

               (2)     Failure to report conduct by an employee, contractor, officer, or
                       director that a reasonable person under the circumstances should have
                       known was a violation of law;

               (3)     Failure to report a violation of the Standards of Conduct by any
                       employee, contractor, officer, or director that a reasonable person
                       under the circumstances should have known violated the Standards;

               (4)     Knowingly or willfully obstructing any government investigation or
                       audit.

       Human Resources and the RCO must establish an appropriate schedule of penalties, including
possible termination, which shall be applicable to violations of this Comprehensive Compliance
Program. The RCO also will take steps to ensure that the applicable disciplinary guidelines are well
publicized throughout the organization.

        An employee or independent contractor whose conduct would otherwise justify termination
may have a lesser discipline imposed depending upon (a) whether the employee or independent
contractor reported his or her own violation; (b) whether the report constitutes Organogenesis’s first
notice of the violation and the employee’s or contractor’s involvement; and (c) whether the employee
or independent contractor has provided full and complete cooperation during the RCO’s investigation
of the violation.

       G.      Establishment of an Ongoing Program of Compliance Monitoring

        This Compliance Program is intended to adapt to changes in the law and to Organogenesis’s
operation and experiences. The Program itself will be reviewed regularly to assess how it is working.
As part of this process, the RCO will prepare an annual report for senior management and the Board of
Directors that describes the general compliance efforts that Organogenesis has undertaken. This report
also will describe any changes that are needed in the implementation or operation of the Compliance
Program to ensure its efficiency or effectiveness. The annual report will incorporate substantive
learning about risk areas and risk management learned from periodic audits and reviews, complaint-
driven investigations, employee and contractor questions, exit interviews and the like.

                                                 5
         If anything in the report identifies areas of possible non-compliance, the RCO will report that
fact to senior management and, when necessary, the Organogenesis Board of Directors. Operation of
the Compliance Program increases the likelihood of preventing unlawful and unethical behavior.
However, even an effective Compliance Program may not prevent all violations of applicable laws.
As such, our Compliance Program requires Organogenesis to respond promptly to potential violations
of our Standards of Conduct or of applicable law, take appropriate disciplinary action, assess whether
the violation is in part due to gaps in our policies, practices, or internal controls, and take action to
prevent future violations. In addition to assessing the Compliance Program annually and making
recommendations to the Board for needed responses to concerns, the RCO coordinates these tasks in
an ongoing manner throughout the year and ensures the Compliance Program is promptly revised to
reflect changes in the law or industry standards.

                                      Standards of Conduct

       A.      Employment at or Affiliation with Organogenesis

       Organogenesis will take reasonable steps to avoid employing or contracting with any
individual or entity who (a) has been convicted of a criminal offense related to health care, or (b) is
debarred, excluded or is otherwise ineligible for participation in Federal or State health care programs.
 Organogenesis will make every reasonable and lawful effort to obtain this information when it screens
employment or independent contractor applications. For each new director, officer, employee or
independent contractor Organogenesis will require:

               (1)     A reference check;

               (2)     A review of (a) the Cumulative Sanctions Report maintained by the
                       OIG of the Department of Health and Human Services (“OIG”)
                       (www.dhhs.gov/progorg/oig) and (b) the List of Persons Excluded
                       from Federal Procurement and Non-Procurement Programs
                       maintained by the GSA (www.arnet.gov/epls).

       The performance of these background investigations shall be documented and maintained in
the appropriate personnel or contract files. Exclusion list reviews will be repeated periodically and as
needed for individuals and entities with responsibilities for sales and marketing, and records of these
periodic reviews also will be maintained in the appropriate personnel or contract files.


       B.      Conduct of Organogenesis’s Business in a Legal and Ethical Manner

       Organogenesis expects that all officers, employees, agents, and independent
contractors will:

               (1)     Understand applicable laws, rules, and the Standards of Conduct and
                       all associated policies to the degree needed for them to carry out their
                       responsibilities in accordance with such laws, Standards, and
                       policies.
                                                    6
               (2)     Understand applicable laws, rules, and the Standards of Conduct and
                       all associated policies to the degree needed to identify situations
                       where other individuals may put Organogenesis at risk of violating
                       such laws, rules, Standards, or policies.

               (3)     Promptly contact the RCO whenever there is a question as to whether
                       or not particular conduct violates the law or the Standards of Conduct
                       or associated policy.

               (4)     Attend any Organogenesis-sponsored compliance training, as it
                       relates to job functions.

               (5)     Report to the RCO any pending criminal investigations involving
                       health care fraud of which they are a target or any pending
                       proceedings against them that could result in them being excluded or
                       debarred.

               (6)     Not commit or tolerate any conduct that may put the company at risk
                       of violating the law or the company’s ethical principles and Standards
                       of Conduct.

       C.       Compliance with the Law

       Organogenesis will operate all aspects of its business in compliance with all applicable
healthcare Federal, State and Local laws and regulations.

               (1)     Healthcare Fraud and Abuse Laws

        Organogenesis will comply with all applicable Federal and State healthcare fraud and abuse or
“anti-kickback” laws and regulations, including the federal Anti-Kickback Statute (42 U.S.C. §1320a-
7b(b)) and the Public Contract Anti-Kickback Act ((41 U.S.C. §§ 51-58), as well as with all applicable
provisions of the Federal False Claims Act. (31U.S.C.§3729 et seq.). The fraud and abuse laws
prohibit, among other things, payment or receipt of kickbacks and other forms of improper
“remuneration” in return for purchasing, leasing, ordering or recommending the purchase, lease or
ordering of any goods, facilities, services or items covered under the benefits of Federal or State health
care programs.

        Common business practices such as providing discounts, rebates, or services to customers may
have potential fraud and abuse law implications if Organogenesis does not document and structure
these practices properly. Inappropriate consulting arrangements or educational or research grants also
may have potential fraud and abuse law implications.




                                                   7
        The Federal False Claims Act prohibits submission or causing the submission of fraudulent
claims to Medicare and other Federal and State programs. Only true and accurate reimbursement
information may be provided to customers. The Federal False Claims Act also prohibits the filing of
incorrect reports if the result of the filing may be a reduction in Organogenesis’s financial obligations
to the government.

               (2)     Food and Drug Laws

        Organogenesis will comply with all applicable laws and regulations and all Organogenesis
policies, procedures, rules and practices that govern the research, development, manufacture, and
distribution medical devices approved by under the Federal Food, Drug and Cosmetic Act.

       D.      Compliance with Industry Standards

       Organogenesis will comply with recommendations included in the OIG’s Compliance
Guidance for Pharmaceutical Manufacturers and the PhRMA/AdvaMed Code on Interactions
with Health Professional. Employees must follow the PhRMA/AdvadMed Code’s requirements
whenever they interact with customers, potential customers or their representatives who are
licensed health professionals (including, but not limited to, physicians, nurses, and pharmacists),
medical students, or members of drug formulary committees. A copy of the PhRMA Code may
be viewed and downloaded at http://www.phrma.org/files/PhRMA%20Code.pdf. A copy of the
AdvaMed code can be viewed and downloaded at http://www.advamed.com/publicdocs/coe.html
.

       E.      Conflicts of Interest

        Employees must avoid any investment, interest, activity or association that interferes, or might
interfere with, their obligation to perform responsibilities in the best interests of the Organogenesis.

       F.      Protection of Confidential Information

       The disclosure of confidential information regarding Organogenesis’s business or scientific
operations, whether intentional or accidental, may adversely affect the financial stability and
competitive position of Organogenesis as well as the job security of employees.

        Employees shall not, without the written consent of senior management, during the term of
employment or thereafter, use, directly or indirectly, for the personal benefit of themselves or others,
or disclose to others, any confidential information of Organogenesis or of other entities obtained
during the course of employment at Organogenesis.




                                                   8
        Employees shall not seek or accept confidential information of a competitor in an illegal or
unethical manner, and if information is offered or given that is reasonably viewed as having been
obtained through illegal or unethical means, or even accidentally, the employee shall immediately
report the matter to the RCO.

       G.      Gifts and Entertainment

        Employees shall not seek, accept, offer, promise or give any payment, fees, loans, services or
gifts from or to any person or firm as a condition or result of doing business with Organogenesis.
Businesses courtesies, gifts and entertainment must comply with the requirements of the PhRMA
Code.

       Organogenesis has established and will enforce an annual limit on the value of gifts,
promotional materials, and items or activities – each of which must individually comply with the
requirements of the PhRMA Code – that may be given to a California-licensed medical or health care
professional. This limit is $500.00.

       H.      Maintenance of the Accuracy and Integrity of Books and Records

        Organogenesis’ books, records and accounts must accurately reflect the nature of the
transactions recorded. This includes, but is not limited to, financial transactions, expense reports,
activity reports and other documents used in the normal course of business.

       I.      Dealings with Government Agencies

        Any communication with a government agency must be responsive, accurate, and complete.
Any data or other information provided to a government agency must be accurate, complete, and
include an explanation of any omission or inability to respond. All government agents will be treated
with respect. Any inquiry from a government agent outside the normal course of ministerial
interactions for purposes of compliance with mandatory reporting requirements will be referred to the
RCO, Chief Financial Officer, and the Chief Executive Officer. In no event will any employee be
prohibited from speaking voluntarily with a government agent engaged in an investigation or an
enforcement action, although they may be advised that they are not obligated to speak with an agent.

       J.      Compliance with Employment Laws

        It is the policy of Organogenesis to provide employment opportunities without regard to race,
religion, color, national origin, sex, age, ancestry, citizenship, veteran status, marital status, sexual
orientation or disability, or any other reason prohibited by law. Decisions as to hiring, promotion and
other aspects of the employment relationship are based solely upon job-related qualifications.

        Organogenesis also prohibits sexual harassment, as well as harassment based on any of the
other characteristics listed above, and will take appropriate action to eliminate prohibited harassment
and remedy the effects of such harassment.

                                                   9
       K.      Appropriate Use of Electronic Media

        Organogenesis provides access to and use of electronic mail, voicemail, the Internet and other
electronic media for business purposes. Organogenesis’s electronic media shall not be used for any
purposes that violate federal, state or local laws.

       L.      Policies Relating to Document Retention and Destruction

        Organogenesis will retain those documents that it is required to retain in order to comply with
pertinent laws and regulations and that are needed for its daily operations. Documents will be
retained long enough to satisfy specific legal requirements. Where documents are no longer required
to be maintained by law or by legitimate business needs, they may be destroyed but shall be done in
accordance with the company’s policies.

       The basic rule allowing destruction of certain documents shall not apply in the following
circumstances:

               (1)     Service of legal process;

               (2)     Inquiries indicating the commencement of litigation; or

               (3)     Notice from the RCO.

       Under these circumstances, no documents should be destroyed until written approval has been
received from the RCO. Contact the RCO if you are uncomfortable with or have questions about the
appropriateness of destroying certain documents.




                                                   10